Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot study

Evaluation of safety and efficacy of autologous stentless mitral valve replacement: pilot study - Stentless mitral valve replacement: pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026020

Enrollment

Registered

2017-03-31

Start date

2017-03-31

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mitral valve stenosis, mitral valve stenosis and regurgitation

Interventions

Autologous pericardial stentless mitral valve replacement

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.severe mitral stenosis, or mitral stenosis and regurgitation, no indication of valve plasty. 2. no indication for catheter intervention treatment 3. mitral valve stenosis: post mitral valve replacement using bioprosthetic valve. 4. mitral valve stenosis: post mitral valve replacement using mechanical valve. 5. Congenital mitral valve stenosis.

Exclusion criteria

Exclusion criteria: 1. Malignancy 2. Hemodialysis 3. Included other clinical study 4. Myocardial infarction within 6 months 5. Strole within 6 months 6. Coronary intervention within 1 months 7. Indication for other cardiac diseases (tricuspid, atrial fibrillation excluded) 8. sever left ventricular dysfunction 9. Conventional treatment is expected to be the best.

Design outcomes

Primary

Measure	Time frame
Presence of mitral valve regurgitation 2 weeks after surgery	—

Secondary

Measure	Time frame
Presence of adverse event wiyhin 12 months after surgery	—

Countries

Japan

Contacts

Public ContactSatoshi Numata

Kyoto Prefectural University of Medicine Cardiovascular surgery

snumat@yahoo.co.jp0752515752

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026